Study to Evaluate the Safety and Tolerability of EP0042

Phase 1

Recruiting

• Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia
• Interventions: Drug: EP0042

• Registration Number: NCT04581512
• Lead Sponsor: Ellipses Pharma

Brief Summary

A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Start: 2020-11-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Module 1 EP0042	EP0042	Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.	First cycle of treatment (28 Days)	Incidence of dose-limiting toxicities (DLT)

Trial Locations

Locations (6)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

University College London Hospital; 🇬🇧 London, United Kingdom

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

The Royal Marsden; 🇬🇧 London, UK, United Kingdom

The Christie Hospital; 🇬🇧 Manchester, United Kingdom